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Dr. Douglas L. Packer, MD, FHRS, Mayo Clinic, Rochester, MN

"Jill and I put you and your work in our prayers every night. What you do to help people through this [A-Fib] process is really incredible."

Jill and Steve Douglas, East Troy, WI 

“I really appreciate all the information on your website as it allows me to be a better informed patient and to know what questions to ask my EP. 

Faye Spencer, Boise, ID, April 2017

“I think your site has helped a lot of patients.”

Dr. Hugh G. Calkins, MD  Johns Hopkins,
Baltimore, MD


Doctors & patients are saying about 'Beat Your A-Fib'...


"If I had [your book] 10 years ago, it would have saved me 8 years of hell.”

Roy Salmon, Patient, A-Fib Free,
Adelaide, Australia

"This book is incredibly complete and easy-to-understand for anybody. I certainly recommend it for patients who want to know more about atrial fibrillation than what they will learn from doctors...."

Pierre Jaïs, M.D. Professor of Cardiology, Haut-Lévêque Hospital, Bordeaux, France

"Dear Steve, I saw a patient this morning with your book [in hand] and highlights throughout. She loves it and finds it very useful to help her in dealing with atrial fibrillation."

Dr. Wilber Su,
Cavanaugh Heart Center, 
Phoenix, AZ

"...masterful. You managed to combine an encyclopedic compilation of information with the simplicity of presentation that enhances the delivery of the information to the reader. This is not an easy thing to do, but you have been very, very successful at it."

Ira David Levin, heart patient, 
Rome, Italy

"Within the pages of Beat Your A-Fib, Dr. Steve Ryan, PhD, provides a comprehensive guide for persons seeking to find a cure for their Atrial Fibrillation."

Walter Kerwin, MD, Cedars-Sinai Medical Center, Los Angeles, CA


Stroke Risk

A-Fib Patients Study: After Brain Hemorrhage, Back on Anticoagulation?

Sometimes I just can’t understand some of the research studies done about Atrial Fibrillation such as this one. I can not wrap my head around this recent study from the Netherlands (APACHE-AF).

They studied A-Fib patients who survived intracerebral hemorrhage after being treated with anticoagulation for atrial fibrillation. Their hemorrhagic stroke was “anticoagulant-associated”. Seven to 90 days after their hemorrhage, patients were either put back on anticoagulation (50 patients) or avoided anticoagulation.

WHAT?! How can you put someone back on an anticoagulant which probably caused their hemorrhagic stroke in the first place?
These researchers certainly knew the alternative options to taking anticoagulants.

This study was done at 16 hospitals in the Netherlands but was nevertheless very small. Most patients who did suffer a hemorrhagic stroke either died or were severely disabled. Few survived. That’s why there were so few patients in the study.

Further Damage From Anticoagulation

Not surprisingly, after a minimum follow-up of 6 months (a very short follow-up), 26% of the apixaban group had non-fatal strokes or vascular death. The patients on antiplatelet therapy (26) or no anticoagulation didn’t do very well either.

The researchers themselves concluded, “Patients with atrial fibrillation who had an intracerebral hemorrhage while taking anticoagulants have a high subsequent annual risk of non-fatal stroke or vascular death.”

Did I Miss Something?

How can you put someone back on an anticoagulant, even Eliquis, when anticoagulants probably caused their hemorrhagic stroke in the first place? This seems both ethically wrong and wrong-headed.

Did I miss something important? If anyone wants to share their view of this study with me, send me an email.

Reference
Schreuder, F. et al.  Apixaban versus no anticoagulation after anticoagulation-associated intracerebral haemorrhage in patients with atrial fibrillation in the Netherlands (APACHE-AF): a randomized, open-label, phase 2 trial. The Lancet Neurology, November 2021.  https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(21)00298-2/fulltext DOI:https://doi.org/10.1016/S1474-4422(21)00298-2

2022 AF Symposium: Procedural Anticoagulation with LAA Closure Devices for A-Fib Patients

In this report from the 2022 AF Symposium, Dr. Luigi Di Biase of the Albert Einstein College of Medicine, Bronx, NY gave a presentation on “Peri and Post Procedural Anticoagulation with LAA Closure Devices―An Evolving Story”.

In particular, he is talking about the Watchman occlusion device to close off an A-Fib patient’s Left Atrial Appendage. His focus is on the anticoagulation protocol following the procedure involving, that is, the drug regime for patients in the months afterward. e.g., DOACs, aspirin and clopidogrel.

This is a short report, a quick read, go to Procedural Anticoagulation with LAA Closure Devices―An Evolving A-Fib Story.

(Finally) A Head-to-Head Comparison of Anticoagulants for A-Fib: Eliquis vs Xarelto

The most commonly prescribed direct-acting anticoagulants (DOACs) for A-Fib patients are Eliquis (generic name: apixaban) and Xarelto (generic name: rivaroxaban).

Direct-acting anticoagulants (DOACs) were introduced in the early 2010s, but most of the testing has been against warfarin, not against other DOACs. Finally, thanks to the researchers of two retrospective studies, A-Fib patients now have a head-to-head comparison of Eliquis versus Xarelto.

Study 1: Stroke and Bleeding Risks

A recent retrospective study (Fralick, M. et al) looked at 6 years of prescription data for atrial fibrillation patients from the Nationwide Healthcare Claims Database (NPIC). A-Fib patient group sizes were matched (39,351 each). Mean age was 69 years, 40% were women and follow up was 288–291 days.

Significant Findings 

Eliquis patients had significantly lower incidence of major bleeding (12.9 vs 21.9 events-per-1K-person-yrs.)

1. Eliquis patients had significantly lower rates of stroke or systemic embolism (6.6 vs 8.0 events per 1000 person-years) compared to Xarelto.

2. Eliquis patients had a significantly lower incidence of major bleeding, defined as gastrointestinal bleeding or intracranial hemorrhage (12.9 vs 21.9 events per 1000 person-years).

Researchers Conclusion (Fralick, M. et al): In routine care, adults with atrial fibrillation prescribed apixaban had a lower rate of both ischemic stroke or systemic embolism and bleeding compared with those prescribed rivaroxaban.

Study 2: Stroke and Bleeding Risks

A second retrospective study (Ray, W. et al) looked at 581,451 atrial fibrillation patients 65 years or older who were enrolled in Medicare from 2013–2018. A-Fib patient group sizes were Rivaroxaban, 227,572 and Apixaban, 353,879. Follow up was for 4 years, through November 30, 2018. Mean age was 77.0 years; 50.2% were women (291 966).

Significant Findings 

Xarelto had substantially more nonfatal extracranial bleeding (39.7 vs 18.5 events-per-1K-person-yrs.)

1. Xarelto patients had more hemorrhagic events including fatal extracranial bleeding (1.4 vs 1.0 per 1000 person-years)

2. Xarelto had more nonfatal extracranial bleeding (39.7 vs 18.5 per 1000 person-years)

3. Xarelto had more fatal ischemic/hemorrhagic events (4.5 vs 3.3 per 1000 person-years)

4. Xarelto had more “total mortality” (44.2 vs 41.0 per 1000 person-years)

Researchers Conclusions and Relevance (Ray, W. et al):  Among Medicare beneficiaries 65 years or older with atrial fibrillation, treatment with rivaroxaban compared with apixaban was associated with a significantly increased risk of major ischemic or hemorrhagic events.

Eliquis vs Xarelto…and the Winner is…

Eliquis (apixaban)! In routine care, Eliquis was found to be both more effective and safer than Xarelto.

As patients, we should pay particular attention to the fact that Eliquis had significantly lower incidence of major bleeding (gastrointestinal bleeding or intracranial hemorrhage) than Xarelto (12.9 vs 21.9 events). And that Xarelto had increased nonfatal extracranial bleeding (39.7 vs 18.5 events) compared to Eliquis.

These differences in bleeding weren’t just “statistically significant” but were really alarming. Major, red flag warning important. Particularly for older people who are more prone to bleeding problems.

Alert: There is anecdotal evidence that some healthcare insurers are pushing patients to switch from Eliquis to Xarelto, despite the above research.

Be Your Own Best Patient-Advocate

Whether or not to take anticoagulants and which one is one of the most difficult decisions you and your doctor must make.

All the results cited above were “significant” and should be taken into account when choosing an anticoagulant.

If you are taking Xarelto, you should talk with your doctor about switching to Eliquis.

Learn all you can about your health conditions. A well-informed patient is welcomed by your doctors and healthcare caregivers. (If not, consider changing doctors.)
References
• Fralick, M. et al. Effectiveness and Safety of Apixaban Compared With Rivaroxaban for Patients With Atrial Fibrillation in Routine Practice: A Cohort Study. APC Journals, Annals of Internal Medicine. April 7, 2020. https://www.acpjournals.org/doi/10.7326/M19-2522

• Ray, W. et al. Association of Rivaroxaban vs Apixaban With Major Ischemic or Hemorrhagic Events in Patients with Atrial Fibrillation. JAMA. 2021;326(23):2395-2404. https://jamanetwork.com/journals/jama/article-abstract/2787319 doi:10.1001/jama.2021.21222

• Dressler, D. et al. Apixaban Might Be Safer and More Effective Than Rivaroxaban for Atrial Fibrillation. NEJM Journal Watch, Ann Intern Med 2020 Mar 9. https://www.jwatch.org/na51065/2020/03/09/apixaban-might-be-safer-and-more-effective-rivaroxaban

• The FH NPIC (National Private Insurance Claims) database. Includes information found on medical and dental claim forms for billions of services billed through private health insurance. https://www.fairhealth.org/custom-solutions/claims-data 

 

2022 AF Symposium: The LOOP Study–Implications for Clinical Practice

Last week, I published my Overview of the 2022 AF Symposium held in January in New York City. You can find it on my page, My Summary Reports Written for Atrial Fibrillation Patients.

The LOOP Study – Implications for Clinical Practice and Future Trials” was presented by Dr. Andrea Russo of Cooper University Hospital in Camden, New Jersey.

Dr. Andrea Russo

Dr. Andrea Russo

A-Fib Strokes More Dangerous: Dr. Russo described how one-third of strokes are due to A-Fib. And these strokes are more severe and debilitating than those not associated with A-Fib. Many were not diagnosed with Atrial Fibrillation until after they had a stroke or heart attack.

The LOOP Study Research: The researchers posed the questions: Is all A-Fib is worth seeing or worrying over? “Does all detected A-Fib require anticoagulation?” Is A-Fib lasting more than 6 minutes but less than 24 hours duration, really a threat?

From 4 centers in Denmark, study patients received the Medtronic Reveal LINQ LOOP Implantable Recorders (ILR), the Reveal LINQ to investigate…. continue reading The Loop Study.

A-Fib Stroke Risk: The LOOP Study–Implications for Clinical Practice and Future Trials

2022 AF Symposium

The LOOP Study–Implications for Clinical Practice and Future Trials

Dr. Andrea Russo of Cooper University Hospital in Camden, New Jersey gave a talk on “The LOOP Study – Implications for Clinical Practice and Future Trials”.

Dr. Andrea Russo

Dr. Andrea Russo

A-Fib Strokes More Dangerous

She described how one-third of strokes are due to A-Fib. And these strokes are more severe and debilitating than those not associated with A-Fib.

Asymptomatic A-Fib may not be diagnosed until after someone has a stroke or heart attack. Dr. Russo described how previous studies defined “device detected A-Fib” as lasting more than 6 minutes but less than 24 hours duration without a prior diagnosis of A-Fib.

The LOOP Study Research

From 4 centers in Denmark, the LOOP Implantable Recorder Study investigated whether anticoagulation can prevent stroke in patients with high risk of stroke.

Participants: In the study, 318 patients, with no prior A-Fib, were over 70 years old (average age was 75 or over) and had at least one risk factor for stroke. They each received an implantable loop recorder (ILR), the Reveal LINQ (by Medtronic).

The control group received standard care (an annual interview with a study nurse and typical interactions with the participant’s general practitioner.)

Patients were monitored and followed for 2-3 years (medium follow-up 64 months).

Study Results

For both groups, the primary outcome was stroke or systemic embolism. Anticoagulation was recommended if someone had A-Fib for 6 minutes or longer.

A-Fib was detected in 32% of the implanted loop recorder group while in only 13% of the control group who received usual care.

There was no significant difference between the groups in major bleeding and hemorrhagic stroke.

Of the LOOP group, 4.5% suffered a primary outcome (stroke or embolism) compared to 5.6% of the control group.

Short Duration A-Fib Not a Risk

The researchers posed the question: Is all A-Fib worth seeing or worrying over? “Does all detected A-Fib require anticoagulation?” Is 6 minutes of A-Fib really a threat?

Dr. Russo cited other studies such as ASSERT where 6-24 hours of A-Fib wasn’t significant as a risk of stroke, whereas over 24 hours duration was. (See my report: How Long Does It Take for an A-Fib Clot to Form? The ASSERT Clinical Trial )

Researchers also asked: What other considerations should be examined? What about A-Fib burden?

Editor's Comments about Cecelia's A-Fib storyEditor’s Comments

Dr. Russo is going against the grain of conventional A-Fib thought by suggesting that 6 minutes of A-Fib is not a serious threat or risk of developing an A-Fib stroke.

If you only have an occasional, short episode of A-Fib, you may not need an anticoagulant. If your doctor insists that you take an anticoagulant, it might be time to get a second opinion.

Remember that anticoagulants are considered high risk drugs. They should only be prescribed if there is a real risk of stroke.

If you find any errors on this page, email us. Y Last updated: Friday, February 25, 2022

Return to 2022 AF Symposium Reports

Anticoagulation CHA2DS2-VASc Clinical Guidelines to Prevent A-Fib Stroke

by Steve S. Ryan, PhD

Background: “Guideline for the Management of Patients With Atrial Fibrillation” is official policy of the American College of Cardiology (ACC) and the American Heart Association (AHA). For clinical practices, they serve as a foundation for the delivery of quality cardiovascular care.

When you develop Atrial Fibrillation, you are at increased risk of clots and stroke. To help A-Fib doctors determine your risk for stroke or heart attack, they use the CHA2DS2-VASc assessment tool.

Not all doctors agree with its recommendations, some find serious fault with it. One of them is Dr. Mintu Turakhia, Professor of Cardiovascular Medicine at Stanford University.

The original 2001 CHA2DS2 assessment tool was revised in 2012 to the current CHA2DS2-VASc.

“CHA2DS2-VASc is a stain on our field.” This statement by Dr. Mintu Turakhia at Stanford Un., CA, was made at the 2022 AF Symposium. A bold statement. This quote reflects the mixed feelings doctors have about these recommendations from Guidelines for the Management of Patients with Atrial Fibrillation.

But for better or worse, our doctors have to live with them. These Guidelines have become, in effect, the law of the land.

As patients we need to understand how these Guidelines work and what they mean for us when we have A-Fib.

CHA2DS2-VASc Risk Assessment

Here’s the CHA2DS2-VASc Risk Assessment tool. Try it—add up your own risk score.

Risk FactorRisk Score
Age 65-74 “A”

Age over 75 “A2”

+1

+2

Female sex “Sc”+1
CHF (Congestive Heart Failure) “C”+1`
Hypertension (Uncontrolled High Blood Pressure) “H” (Over 140/90)+1
Stroke/TIA “S2”+2
Vascular Disease (Heart Attack, etc.) “V”+2
Diabetes “D”+1
Total score:

How’d you do? According to the Guidelines, any risk score higher than zero for men and 1 for women dictate you should be on an anticoagulant.

Did you notice…that just being a 65-year-old female (2 pts.) automatically rates you at risk of stroke? Not taken into account were the patient’s fitness, level of activity, or even a family history of stroke. Is this an accurate assessment of stroke risk or is something lacking?

Beware: Guidelines “Recommend” Almost Everyone with A-Fib be on Anticoagulation

Only people with a risk score of 0 (males) and 1 (females) are considered low risk patients. What this means in practice is that almost everyone with A-Fib is supposed to be on an anticoagulant for life.

In addition, Dr. Gregory Lip, who was instrumental in developing the CHA2DS2-VASc guidelines, states that even a risk factor of 0 can “identify those who would still substantially benefit from oral anticoagulation.”

In other words, even those with a risk factor of 0 may be put on anticoagulants. (Really?)

Gender as a Risk of Stroke: In the Guidelines, a woman with A-Fib is automatically given one point on the stroke risk scale simply because of being female, no matter how healthy she may be otherwise. (“Sc” stands for sex i.e., female gender.)

(I find that this is not justified by research; Is this a not-very-subtle form of gender bias? See my post: Israeli Study Contradicts Recent CHA2DS2-VASc Guidelines.)

The Exception: controlled Hypertension: If you have hypertension which is controlled (by for example taking a drug like lisinopril) and is under 140/90, you are not considered to have a risk factor for stroke.

Anticoagulants are High Risk Drugs

Unlike what you hear in today’s advertising, anticoagulants are not like taking vitamins. They work by increasing your risk of bleeding. The Guidelines do not discuss that “Oral anticoagulants are high risk medications.”

Unlike what you hear in today’s advertising, anticoagulants are not like taking vitamins.

Dr. John Day describes his patient (and personal friend) Bob who, was on anticoagulation for 10 years. Basically he became a vegetable with early dementia. He remained on an anticoagulant even though he had been A-Fib free after a catheter ablation. (Read the story in my post: The Risks of Life-Long Anticoagulation Therapy)

But because of these guidelines, many more people will be put on anticoagulants, particularly women, and develop other health problems. (Read more: Anticoagulants Increase Risk of Hemorrhagic-Type Strokes ).

Added Motivation to Prescribe Anticoagulants

One of the reasons doctors prescribe anticoagulants at the drop of a hat is the risk of a malpractice lawsuit.

The Guidelines are “in effect” dictates. If a doctor doesn’t follow these guidelines, and a patient has a stroke, that doctor is almost guaranteed a losing malpractice lawsuit. The first thing a trial lawyer will point out to an arbitrator or jury is that the doctor didn’t follow current guidelines.

Anticoagulation: Newer Interpretations of the Guidelines

Reflecting the absurdity of one point for female gender, today’s anticoagulation “recommendations” (dictates) are the same for men with 1 point as for women with 2 points.

(It sounds like the writers of the Guidelines recognize their error and bias against women but won’t actually change the guidelines so as not to lose face and acknowledge they were wrong.)

Female Patients: Is Your Doctor Aware of this Modification? Many doctors are not aware of this new interpretation of the guidelines and automatically put women with A-Fib on anticoagulants for life, without regard to anything else.

How Medical Guidelines can Create Pharma Financial Windfall

Medical Guidelines can have an immense impact on the lives of patients. And an immense boost to revenue for the pharmaceutical industry, often overnight.

Overnight nearly half of US adults were suddenly classified as having hypertension.

For instance, in 2017, new guidelines for the management of high blood pressure were issued by the ACC and AHA. The threshold for hypertension was lowered from 140/90 mm Hg (or higher) to 130/80 mm Hg.

Overnight nearly half of US adults were suddenly classified as having hypertension. This means doctors would be prescribing a lot more medications, to a lot more patients. What a boom to the sales of thiazide diuretics, ACE inhibitors, ARBs, and calcium channel blockers.

This one change in the medical guidelines was a financial windfall for drug companies and represents a huge increase in customers (many for a lifetime). Doctors complained, patients complained, but not the drug companies.

Don’t Just be a Number on a Risk Assessment Tool!

To take an anticoagulant or not (and, if so, which one) is one of the most important decisions you and your doctor will make.

Don’t just be a number on a risk assessment tool. Educate yourself. Become your own best Patient Advocate.

Start with the posts I’ve mentioned above. Arm yourself with an understanding of anticoagulants and your risk of clots and strokes. Then you need to intelligently discuss this decision with your doctor.

References
• Lip, Gregory CHA2DS2-VASc Score for Atrial Fibrillation Stroke Risk. MDCal.com. URL https://www.mdcalc.com/cha2ds2-vasc-score-atrial-fibrillation-stroke-risk

• Baltic, S. New Oral Anticoagulants Can Require Careful Dosing Too. Medscape/Reuters Health Information. December 29, 2016. (Quote: Dr. Daniel M. Witt and Dr. Alisyn L. Hansen of the University of Utah College of Pharmacy.) URLL:  http://www.medscape.com/viewarticle/873821?src=wnl_edit_tpal

• AHA/ACC/HRS 2019 Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation. DOI: 10.1016/j.jacc.2019.01.011

• Bakris, G, Sorrentino, M. Redefining Hypertension — Assessing the New Blood-Pressure Guidelines. N Engl J Med 2018; 378:497-499. DOI: 10.1056/NEJMp1716193

 

Who’s at Higher Risk of a Recurrent A-Fib Stroke?

You’ve had an A-Fib stroke—and you survived—hoorah! Now you wonder…am I more prone to a recurrent stroke? The answer may lie with how often your A-Fib episodes occur (i.e., paroxysmal versus persistent/permanent).

A recent observational research study from Japan posed this question:

In patients with a history of ischemic stroke and atrial fibrillation (A-Fib), is there a difference in the risk of future stroke between those with paroxysmal versus permanent atrial fibrillation?

What’s the Risk of a Recurrent A-Fib Stroke?

The SAMURAI-NVAF study included 1,192 A-Fib patients who had suffered an acute or ischemic stroke (where a clot blocks blood flow to the brain) and followed them for around 1.8 years.

Study patients were hospitalized within 7 days of stroke between April 2011 and March 2014 at 18 Japanese stroke centers. The average age was 77.7 ± 9.9 years, 44% were women, and 63.6% had persistent A-Fib.

Findings: Patients with Persistent A-Fib at Higher Risk of Recurrent Stroke

The researchers found a higher risk of ischemic stroke (or systemic embolism) in those with persistent A-Fib. Persistent patients also had higher rates of both ischemic strokes and transient ischemic attacks (TIAs).

Comorbidities means presence of two or more diseases or medical conditions in a patient.

Patients with persistent A-Fib were in general less healthy. They were more likely to have comorbidities: congestive heart failure, liver problems, higher alcohol use, and more disability after the first stroke.

Patients with paroxysmal A-Fib were associated with increased odds of “functional independence” 3 months after their A-Fib stroke (i.e., less likely to be disabled after the stroke).

Why More Stroke Risk When Persistent? The researchers noted that patients with persistent A-Fib have larger Left Atrial Appendage (LAA) size and more severe blood flow problems (lower LAA ejection fraction). … Continue reading this report…->

How Long Does It Take for an A-Fib Clot to Form? The ASSERT Clinical Trial

Background: Of A-Fib stroke patients, 23% die and 44% suffer significant neurologic damage. This compares to only an 8% mortality rate from other causes of stroke.

How Long Does It Take for a Clot to Form? Some doctors say it only takes around 5 minutes for an A-Fib clot to form and cause a stroke that kills you.

This is generally not accepted thinking among Cardiologists and Electrophysiologists (EPs). The ASSERT clinical trial gives us some insights.

How Do Clots Form and Cause Strokes?

Clots aren’t formed instantaneously. It takes a while for blood to pool and form a clot of significant size. If you have a ten-minute attack of A-Fib, for example, it’s unlikely a clot/stroke will develop.

When someone is in A-Fib, blood is not being effectively pumped out of the left atrium. There are spots where blood can pool such in as the Left Atrial Appendage (LAA). This pooled blood can form a clot.

When the left atrium again beats normally, it can push this clot downstream into the left ventricle and into the bloodstream. From there, the clot can travel into the brain causing an ischemic (blocking) stroke.

Patients in permanent A-Fib are at higher risk of clots and stroke. But not in just a few minutes.

(Another risk of A-Fib is a hemorrhagic stroke when a blood vessel bursts, causing bleeding in the brain.)

ASSERT stands for “Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial”.

The ASSERT Study

The ASSERT clinical trial is a fascinating study with data collected by pacemakers and defibrillators (ICDs). Researchers looked at pacemaker patients and their risks of developing Silent A-Fib and stroke. Their primary question was: Do Pacemakers Prevent A-Fib?

A secondary benefit of the study is the A-Fib patient data collected. In particular, when and how long it takes for A-Fib patients to develop a serious risk of stroke.

The study gives us insight into when and how long it takes for A-Fib patients to develop a serious risk of stroke.

Study Description: The ASSERT study enrolled 2,580 patients, 65 years of age or older, with hypertension and no history of A-Fib, in whom a pacemaker or defibrillator (ICD) had recently been installed.

The pacemaker and ICD devices were programmed to detect silent A-Fib (i.e., Subclinical Atrial Tachycardia [SCAF]) when the heart rate reached 190 beats or more per minute lasting more than 6 minutes. The devices were checked at a clinical visit 3 months later. These patients were then followed up for around 2.5 years.

How Long in Silent A-Fib to Significantly Increase Clot/Stroke Risk

In the ASSERT study they found that it took more than 17.72 hours to significantly increase the annual stroke risk. The results of all patients are divided into four quartiles:

Duration Quartile: Time in Silent A-FibAnnual Stroke Risk
≥ 0.86 Hours1.23 %
0.87-3.63 Hours0 %
3.64-17.72 Hours1.18 %
˃ 17.72 Hours4.89 %

Researchers found the annual stroke risks for patients with Silent A-Fib for less that 17.72 hours were similar to the stroke risk for healthy people (which is considered to be 1%).

The ASSERT study basically said that it takes around 24 hours of silent A-Fib to develop a serious clot/risk of stroke (on average 3.1%).

Contrary Interpretation: In a later analysis of the same ASSERT study by Van Gelder (2017), patients with lengths of Subclinical Atrial Tachycardia (SCAF) from 6hrs to 24hrs were not significantly different from patients without SCAF.

Similar Trial Results: The TRENDS study, a prospective, observational study, also used implanted devices and found similar results as the ASSERT study.

Do Pacemakers Work to Prevent A-Fib?

The primary question of the ASSERT study was: Do Pacemakers Prevent A-Fib?
Finding: Pacemakers (continuous overdrive pacing) “does not prevent clinical atrial fibrillation.”

Editor’s Comments

Editor's Comments about Cecelia's A-Fib storyShorter Episodes of A-Fib Not Generally Dangerous: Despite studies such and ASSERT and TRENDS, we still need many more studies on how long it takes for a clot/stroke to form. Probably the most useful data to date does come from the ASSERT study where it took around 24 hours of silent A-Fib before clot/stroke risk was significantly increased.
People with shorter episodes of A-Fib or silent A-Fib, such as may occur after a successful catheter ablation, may not need to be on anticoagulants at all. Remember that anticoagulants are high risk drugs that shouldn’t be taken unless there is a real risk of stroke.

The general consensus is that A-Fib clots/strokes take around 24 hours to develop. In a popular article in Bottom Line Health, Dr. Antonio Gotto, cardiovascular disease specialist at Weill Cornell Medical College in New York City, says it takes one day for a clot to form.

Resources for this article

• Healey, J.S. et al. Subclinical Atrial Fibrillation and the Risk of Stroke. The New England Journal of Medicine 2012; 366:120-129. http://www.nejm.org/doi/full/10.1056/NEJMoa1105575?viewType=Print&viewClass=Print# DOI: 10.1056/NEJMoa1105575

• Glotzer, T. V. et al. The Relationship Between Daily Atrial Tachyarrhythmia Burden From Implantable Device Diagnostics and Stroke Risk―The TRENDS Study. Circulation: Arrhythmia and Electrophysiology, August 4, 2009. 2009;2:474-480. https://www.ncbi.nlm.nih.gov/pubmed/19843914 doi: 10.1161/CIRCEP.109.849638

• Gotto, Jr., Antonio M. Bottom Line Health, Vol 26, November 2012, p. 4.

• Van Gelder, I.C. et al. Duration of device-detected subclinical atrial fibrillation and occurrence of stroke in ASSERT. European Heart Journal, Volume 38, Issue 17. 1 May 2017, Pages 1339-1344, https://academic.oup.com/eurheartj/article/38/17/1339/3059370. doi.org/10.1093/eurheartj/ehx042

Comparing the Effectiveness and Safety of the Direct Oral Anticoagulants (DOACs) in Patients With A-Fib

Anticoagulants are used with high-risk Atrial Fibrillation patients for the prevention of clots and stroke. FDA approved in 2010, Direct Oral Anticoagulant (DOACs) quickly became attractive alternatives to warfarin, the long‐standing standard of care in anticoagulation.

DOACs include dabigatran (Pradaxa), rivaroxaban (Xarelto) and apixaban (Eliquis). (Edoxaban [Savaysa] approval came later.)

The use of the term “Direct Oral Anticoagulants” (DOACs) has replaced the term NOACs (Novel Oral Anticoagulants), but it means the same.

When the FDA approved DOACs (Direct Oral Anticoagulants), they relied on 3 different clinical trials. But these trials only compared a DOAC, like Eliquis, to warfarin, not to the other DOACs.

Someone like myself had to dig deep into the research to find evidence of which DOAC actually tested better/safer of the three. (I found that Eliquis tested better and was safer.)

For more about the DOACs, see my articles: Warfarin and the New Anticoagulants, and my report from the AF Symposium: The New Anticoagulants.

DOACs: Finally a Head-to-Head Comparison

Today there is clinical data comparing the DOACs against each other. (And support my original reports.)

A comprehensive review of 36 randomized control trials and observational studies included over 1 ¼ million patients. The DOACs compared were apixaban, dabigatran, rivaroxaban, and edoxaban. The reviewers found:

▪ For major bleeding: Eliquis (apixaban) “tended to be safer” than Xarelto (rivaroxaban) and Pradaxa (dabigatran) based on both direct and indirect comparisons;

▪ For best treatment: Eliquis had a higher probability of being the best treatment of decreased risk of stroke/systemic embolism;

▪ Highest benefit: Eliquis had the highest net clinical benefit and smallest NNTnet (Number Needed to Treat for net effect, i.e., how many people were helped by it, how many were harmed.)

Reviewers Conclusions

The researchers wrote: “Apixaban (Eliquis) appeared to have a favorable effectiveness-safety profile compared with the other DOACs (NOACs) in AF for stroke prevention, based on evidence from both direct and indirect comparisons.” (Translation: Eliquis was found to be more effective and safer than the other DOACs).

Editor’s Comments:

Editor's Comments about Cecelia's A-Fib storyIn the world of scientific statistics and cautious conclusions, this is about as big an endorsement as you will find: Eliquis is superior to the other anticoagulants.
If you’re on a different DOAC, talk to your doctor about switching to Eliquis.
Know the Risks of Taking Anticoagulants (Blood Thinners): Taking almost any prescription medication has trade-offs. In the case of anticoagulants, on one hand you get protection from having an A-Fib stroke (which often leads to death or severe disability), but on the other hand you have an increased risk of bleeding and other problems. Bleeding events are common complications of anticoogulants.
Is an Anticoagulant Necessary for Me? Be certain you should be on an anticoagulant in the first place. Doctors assess an A-Fib patient’s risk of stroke using a rating scale (called CHA2DS2-VASc). Ask your doctor what’s your risk-of-stroke score. If your score is a 1 or 2 (out of 10), ask if you could take a non-prescription approach to a blood thinner.
Remember Anticoagulants Are High Risk Drugs: Be aware that all anticoagulants are considered high risk drugs.

They aren’t like taking vitamins, though they are certainly better than having an A-Fib (ischemic) stroke. To learn more see: Anticoagulants Increase Risk of Hemorrhagic-Type Strokes.

Resource for this article
Zhang, J., et al. Comparative effectiveness and safety of direct acting oral anticoagulants in nonvalvular atrial fibrillation for stroke prevention: a systematic review and meta-analysis. Eur J Epidemiol (2021). https://doi.org/10.1007/s10654-021-00751-7

More Reports from the 2021 AF Symposium

Each year you’ll find me at the annual AF Symposium. It’s a unique experience. I attend presentations by the most eminent medical researchers, scientists, cardiologists and cardiac electrophysiologists working in A-Fib today.

I’ve published two more summary reports from the 2021 AF Symposium:

Spotlight Session: Javelin VINE Filter to Prevent Stroke

The idea behind the Javelin Medical VINE filter is to catch and stop clots (emboli) trying to travel up into the brain. This is done by inserting the VINE filter into both carotid arteries.(Of all the 5-minute Spotlight Session talks, this is my personal favorite.)

That’s incredibly good news for many A-Fib patients! It’s simple, ingenious, and very effective. Javelin Medical is an Israeli company located in Yokne’am Illit, Israel. Read more.

Live Case: Vein of Marshall Alcohol Ablation2021 AF Symposium Live Streaming Video

The AF Symposium audience watched live streaming video from Houston as Dr. Miguel Valderrabano demonstrated an innovative treatment for A-Fib using Alcohol Ablation of the Vein of Marshall.

In difficult A-Fib cases (persistent, long-term persistent), the Vein of Marshall can contain A-Fib signals (potentials, triggers) which are hard to reach and ablate. Adding ablation of the Vein of Marshall using Ethanol has been proven effective.

Using a 3 mm balloon catheter containing ethanol, he distributed ethanol into the Vein of Marshall starting distally (at the far end of the vein). Read more.

To browse through my other reports, go to 2021 AF Symposium Reports. For reports from other years go to Archive of AF Symposiums Summaries by Year

 

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